Zantac

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Zantac

WARNINGS

No information provided.

PRECAUTIONS

General

Symptomatic response to therapy with ZANTAC (ranitidine hcl) does not preclude the presence
of gastric malignancy.

Since ZANTAC (ranitidine hcl) is excreted primarily by the kidney, dosage should be adjusted
in patients with impaired renal function (see DOSAGE AND ADMINISTRATION).
Caution should be observed in patients with hepatic dysfunction since ZANTAC (ranitidine hcl)
is metabolized in the liver.

Rare reports suggest that ZANTAC (ranitidine hcl) may precipitate acute porphyric attacks
in patients with acute porphyria. ZANTAC (ranitidine hcl) should therefore be avoided in patients
with a history of acute porphyria.

Laboratory Tests

False-positive tests for urine protein with MULTISTIX® may occur during
therapy with ZANTAC (ranitidine hcl) , and therefore testing with sulfosalicylic acid is recommended.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no indication of tumorigenic or carcinogenic effects in life-span
studies in mice and rats at dosages up to 2,000 mg/kg/day.

Ranitidine was not mutagenic in standard bacterial tests (Salmonella, Escherichia
coli) for mutagenicity at concentrations up to the maximum recommended for these
assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats
was without effect on the outcome of 2 matings per week for the next 9 weeks.

Pregnancy

Teratogenic Effects - Pregnancy Category B

Reproduction studies have been performed in rats
and rabbits at doses up to 160 times the human dose and have revealed no evidence
of impaired fertility or harm to the fetus due to ZANTAC (ranitidine hcl) . There are, however,
no adequate and well-controlled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug should be used
during pregnancy only if clearly needed.

Nursing Mothers

Ranitidine is secreted in human milk. Caution should be exercised when ZANTAC (ranitidine hcl)
is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of ZANTAC (ranitidine hcl) have been established in the age-group
of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal
reflux disease and erosive esophagitis, and the maintenance of healed duodenal
and gastric ulcer. Use of ZANTAC (ranitidine hcl) in this age-group is supported by adequate
and well-controlled studies in adults, as well as additional pharmacokinetic
data in pediatric patients and an analysis of the published literature (see
CLINICAL PHARMACOLOGY: Pediatrics andDOSAGE AND ADMINISTRATION: Pediatric
Use).

Safety and effectiveness in pediatric patients for the treatment of pathological
hypersecretory conditions or the maintenance of healing of erosive esophagitis
have not been established.

Safety and effectiveness in neonates (less than 1 month of age) have not been
established (see CLINICAL PHARMACOLOGY: Pediatrics).

Geriatric Use

Of the total number of subjects enrolled in US and foreign controlled clinical
trials of oral formulations of ZANTAC (ranitidine hcl) , for which there were subgroup analyses,
4,197 were 65 and over, while 899 were 75 and over. No overall differences in
safety or effectiveness were observed between these subjects and younger subjects,
and other reported clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity of some older
individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal function,
caution should be exercised in dose selection, and it may be useful to monitor
renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics andDOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal
Function).

Last reviewed on RxList: 12/6/2010
This monograph has been modified to include the generic and brand name in many instances.